title: Phase II clinical trial of pegylated liposomal doxorubicin (JNS002) in Japanese patients with mullerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) having a therapeutic history of platinum-based chemotherapy: a Phase II Study of the Japanese Gynecologic Oncology Group.
abstract: OBJECTIVE
  This study was conducted to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy.
  
  
  METHODS
  Patients who were diagnosed with Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube and peritoneal carcinoma) by histological examination and had received the initial platinum-based chemotherapy were included in the study. The study drug was administered to the patients at 50 mg/m(2) every 4 weeks.
  
  
  RESULTS
  Seventy-four patients were enrolled in the study. All patients had received platinum-based chemotherapy as first-line regimen and more than 90% of patients had also received taxanes. The overall response rate was 21.9% (95% confidence interval, 13.1-33.1%) and 38.4% of patients had stable disease. The median time to progression was 166 days. The major non-haematological toxicities were hand-foot syndrome (Grade 3; 16.2%) and stomatitis (Grade 3; 8.1%). Myelosuppression such as leukopenia (Grade 3; 52.7%, Grade 4; 6.8%), neutropenia (Grade 3; 31.1%, Grade 4; 36.5%) and decreased haemoglobin (Grade 3; 14.9%, Grade 4; 2.7%) were the most common haematological toxicities.
  
  
  CONCLUSIONS
  We confirmed that a 50 mg/m(2) every 4 weeks regimen of PLD was active in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy and toxicity was manageable by dose modification of PLD or supportive care.
authors.affiliation: Department of Medical Oncology, National Cancer Center, Tokyo, Japan. nkatsuma@ncc.go.jp
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Katsumata
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Kamura
authors.forename: Toru
authors.initials: T
authors.lastname: Nakanishi
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hatae
authors.forename: Daisuke
authors.initials: D
authors.lastname: Aoki
authors.forename: Kenichi
authors.initials: K
authors.lastname: Tanaka
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsuda
authors.forename: Shoji
authors.initials: S
authors.lastname: Kamiura
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Takehara
authors.forename: Toru
authors.initials: T
authors.lastname: Sugiyama
authors.forename: Junzo
authors.initials: J
authors.lastname: Kigawa
authors.forename: Keiichi
authors.initials: K
authors.lastname: Fujiwara
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ochiai
authors.forename: Ryo
authors.initials: R
authors.lastname: Ishida
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Inagaki
authors.forename: Kiichiro
authors.initials: K
authors.lastname: Noda
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy*; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007564:Japan; D008081:Liposomes; D008875:Middle Aged; D018200:Mixed Tumor, Mullerian / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D008081:Liposomes; D017671:Platinum Compounds; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin